Women with breast implants continue to report a range of illnesses they attribute to the devices, from pain, weakness and distorted breasts to connective-tissue disease and a rare cancer.

The details of problems with both silicone and saline implants were being offered Monday to a Food and Drug Administration advisory panel at the agency’s headquarters. The panel is hearing testimony from patients, as well as evaluating studies collected by companies and complaints received by the FDA.

Jamee Cook,
head of a women’s group called Breast Implant Victim Advocacy, said she was a paramedic and active when she got implants in 1998. Since then, she said, she experienced chronic fatigue, numbness and migraines—symptoms that were resolved when she had them taken out.

“Women are still complaining of the exact same issues” they complained of in 1992 when silicone implants left the U.S. market, she said. “The FDA has not fulfilled its responsibility to protect patients.”

Nearly three decades after the FDA first pulled silicone breast implants off the U.S. market and then allowed some back on, women continue to report debilitating conditions to the agency. The FDA is revisiting the issue again this year and is grappling with efforts to study which issues are proven and which not proven.

As if to underscore the imprecision, the panel members discussed whether they and the FDA can use existing registries of patients—or might have to rely on new registries not yet created—to understand how serious the scope of the women’s illnesses is.

“Breast implants are not lifetime devices,” the agency said in its analysis for the hearing, which is being held Monday and Tuesday. The devices, the FDA said, clearly lead to local complications like breast pain and asymmetry, scarring and infection. They are linked to a rare cancer of the immune system called anaplastic large-cell lymphoma, from which some patients have died. The agency estimates the cancer occurs in between 1 in 3,000 and 1 in 30,000 cases.

Diana Zuckerman, president of the National Center for Health Research, said her group has done research on 400 women with breast implants who experienced severe symptoms. They were all patients who got the devices for cosmetic reasons. After getting the implants out, 61% said they were “much better,” and 29% were “somewhat better,” Dr. Zuckerman said.

As it has for years, the FDA continues to say “there is not sufficient evidence” to link the devices to systemic rheumatologic or connective-tissue diseases such as joint maladies. But many women with the implants just as adamantly insist that the symptoms they have are due to breast implants.

Implants are of two types, either filled with silicone or saline solution. The main manufacturers are
Allergan
PLC, Ideal Implant Inc., Mentor Worldwide LLC and
Sientra Inc.
This month, the federal agency sent warning letters to Mentor and Sientra, saying they had failed to fulfill requirements on studies to evaluate the safety of implants.

In their prepared testimony, the companies all said that patient safety is paramount to them, and that they haven’t seen in their studies convincing evidence that the systemic rheumatological and neurological illness reported by women are in fact due to implants.

In the case of breast reconstruction, such as following cancer or accidents, a surgical mesh often is implanted, too. The advisory panel of doctors convening this week in Silver Spring, Md., will evaluate on Tuesday the mesh in breast reconstruction.

The FDA generally removed cosmetic silicone breast implants in 1992 from the U.S. market after thousands of complaints from women about the various health problems. When the agency did so, it required companies to submit data on safety to get back on the market. The agency also asked for more data about saline implants.

The agency allowed silicone devices to continue to be used for reconstruction, such as after a mastectomy, and in clinical studies. In 2006, the FDA approved some models of silicone implants, concluding that their benefits and risks were known well enough by then.

The FDA required manufacturers to conduct follow-up studies to gain greater understanding of implant safety, in particular. Because some manufacturers didn’t fully do so, and because there continue to be many implant procedures—an estimated 300,000 in the U.S. alone each year—the unresolved health issues remain of great urgency to many people.